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I've been following stem cell research and the promise it holds for folks w/ MS. They always end the articles with "in 5-10 years". Looks like Texas ain't waiting no more...Texas State Senator Hardcastle talking about adult stem therapy he had for his MS - in Houston. No immune system ablation required. Source is your own adipose tissue. Stem cells expanded to 600 million cells, delivered via IV.

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do you have any news on Celltex? How are they doing with their MSC treatment? As far as I know in quite a few cases there are ongoing clinical trials with MSC treatment. Although, in most such cases they use bone marrow derived MSC instead of adipose that is used in Texas.

This is what I found on Celtex back in February:

"Lotfi says that he has administered cells processed by Celltex to more than 20 people. “Five or six” — including Bertrand — have multiple sclerosis and “four or five” have Parkinson's disease, he says. Lotfi explains that patients sign up for treatment by contacting Novak, and that cells are prepared by removing about five grams of fat — containing roughly 100,000 mesenchymal stem cells — from the patient's abdomen. Over a three-week period, the cells are cultured until they reach about 800 million cells. Lotfi says that patients get at least three injections of 200 million cells each, and that the cells do not take effect for a few months. According to Lotfi, Celltex charges US$7,000 per 200 million cells, and pays Lotfi $500 per injection.

Lotfi says that most of his patients claim to get better after the treatment, but he admits that there is no scientific evidence that the cells are effective. “The scientific mind is not convinced by anecdotal evidence,” he acknowledges. “You need a controlled, double-blind study. But for many treatments, that's not possible. It would take years, and some patients don't have years.”

“The worst-case scenario is that it won't work,” he adds. “But it could be a panacea, from cosmetics to cancer.” He says that Celltex is conducting a trial in which patients “will be their own control”. “If you can compare before and after and show improvement, there's no need for a placebo,” he explains. “How can you charge people, and then give them a placebo?” "

In the above, it seems that Celltex might have already initiated clinical trials on the use of adipose derived MSC.

I had the infusions in May, almost at 3 months now and I'm very impressed with my progress. Yes, they are tracking results under an IRB approved trial, so we will have results on adipose derived stem cells for MS. PM me and I'll send you my detailed tracking report. Or contact me on FB http://www.facebook.com/sammyjo.ldn

I think CCSVI treatment is necessary, but we need stem cells to heal the damaged vein tissue so it doesn't restenose. And the stem cells repair myelin damage too. Here is a public account from Dave Summers who had combination treatment in India for MS, angioplasty for CCSVI + adult stem cells. I am in touch with him, he is continuing to do well.

SammyJo wrote:I had the infusions in May, almost at 3 months now and I'm very impressed with my progress. Yes, they are tracking results under an IRB approved trial, so we will have results on adipose derived stem cells for MS. PM me and I'll send you my detailed tracking report. Or contact me on FB http://www.facebook.com/sammyjo.ldn

I think CCSVI treatment is necessary, but we need stem cells to heal the damaged vein tissue so it doesn't restenose. And the stem cells repair myelin damage too. Here is a public account from Dave Summers who had combination treatment in India for MS, angioplasty for CCSVI + adult stem cells. I am in touch with him, he is continuing to do well.

You said you feel CCSVI treatment is also necessary; out of interest, have you personally had CCSVI treatment?

How did you get access to this treatment? were they running a trial you were lucky to get on? knew someone? simply prepared to pay the costs?

One thing which concerns me about this treatment, is that the MS will eventually return (which is possibly the reason for your belief in CCSVI). I would hate for research to stop or the treatment availability be limited due to this. I would LOVE a couple of years without MS

I know I shouldn't, but when I was watching the video above, the man said something like "Texas was known internationally for its medical innovation". It put a smile on my face, because in Australia, due to the media, they are probably more renown for the death penalty and liberal gun laws (as opposed to Australian gun laws).

Yes, I have had CCVSI treatment 5 times starting in 2009. Restenosed every time. I've had MS for 17 years, since I was 30, I think my vein tissue is just too destroyed. So my hope is the stem cells will repair the veins, as well as the myelin.

It is under an IRB trial, approved by the Texas Sate Board of Health, but it is patient funded, slightly more than the cost of overseas clinics, but I don't have to leave the USA. And there will be results tallied up, so we can determine how effective this is, and hopefully move towards insurance coverage.

>MS will eventually return This treatment is much higher than anything else available, 600 million mesemchymal stem cells from your adipose tissue. So we will see if MS returns or not. If this turns out to be an ongoing therapy, at least is non-toxic.

A while back I did a search, and to my surprise found many clinics were offering "Stem Cell Treatments" in Australia. However, what I noted on all of them, which is very different to the treatment you received, is that the cells are expanded to 600 million cells; in your case. The treatment in Australia, simply extracts the stem cells from the fat, and then reintroduce them. This may work well for arthritis (as shown in the video, which may have prompted my search), where they can inject directly into the joint, but they aren't injecting the stem-cells directly into the CNS for MS.

I will contact the foundation to check if they know of anyone expanding the stem cell numbers from that which are extracted.

SammyJo wrote:Yes, I have had CCVSI treatment 5 times starting in 2009. Restenosed every time. I've had MS for 17 years, since I was 30, I think my vein tissue is just too destroyed. So my hope is the stem cells will repair the veins, as well as the myelin.

It is under an IRB trial, approved by the Texas Sate Board of Health, but it is patient funded, slightly more than the cost of overseas clinics, but I don't have to leave the USA. And there will be results tallied up, so we can determine how effective this is, and hopefully move towards insurance coverage.

>MS will eventually return This treatment is much higher than anything else available, 600 million mesemchymal stem cells from your adipose tissue. So we will see if MS returns or not. If this turns out to be an ongoing therapy, at least is non-toxic.

Hi SammyJo,Did you feel worse after the unsuccesful CCSVI procedures? I would assume that your vein got full of scars. Hopefully, the angioplasty did not cause any major problems for you as collaterals might help out.

As far as I know, in Texas they use expanded cultures, which is good. The high population of MSC that you mentioned should be more useful. I think in Texas they do something similar as in the ongoing FDA controlled clinical trials with the exception that they use adipose tissue in Texas instead of bone marrow. From which what I read I infer that adipose tissue should be better source.

The MSC stem cells should both control the bad immune cells and do some regeneration, so it is not specifically only a regenerative therapy. I really hope that you will experience good results.

A while back I did a search, and to my surprise found many clinics were offering "Stem Cell Treatments" in Australia. However, what I noted on all of them, which is very different to the treatment you received, is that the cells are expanded to 600 million cells; in your case. The treatment in Australia, simply extracts the stem cells from the fat, and then reintroduce them. This may work well for arthritis (as shown in the video, which may have prompted my search), where they can inject directly into the joint, but they aren't injecting the stem-cells directly into the CNS for MS.

I will contact the foundation to check if they know of anyone expanding the stem cell numbers from that which are extracted.

Hi CureOr Bust,there are big differences even among MSC stem cell therapies. The ones without expansion are probably only a snakeoil and worth nothing, only placebo. Expansion is crucial. I doubt you will find a hospital in Australia with this procedure as expansion is usually not allowed. This is why FDA is examining even Texas. You can probably find only clinical tests that you can join. That is also a good choice.

I don't mean to butt in here and interrupt the good flow of dialogue. Just wanted to add a couple of additional comments.

Although still quite unproven I am happy to see the Celltex MSC therapy available for those that wish to receive the treatment (I might even consider it for myself). The in-vitro science and surrogacy evidence looks very promising. Although MSC's don't themselves repair damaged (nerve) tissue (MSC's are the progenitor cells for connective tissues such as bone and cartilage, not active cells like muscles and nerves), MSC's instead possibly direct other cells to do so (at least in the in-vitro Petri dish) by emitting cytokine messenger molecules that instruct repair activity at other cellular level(s). If this also happens in the body then it is not science fiction to think that perhaps it could also result in some restoration of some level of nerve function. In addition to such potential nerve restoration, MSC's also appear to modulate the overactive lymphocytes that are at the root of MS pathology, but this aspect of MSC's appears to be only a temporary effect (which would indicate that if one would like to permanently stop the underlying MS disease activity and progression then a procedure such as HSCT would be required to tacle the entire spreading epitope). The following video of Case Western research scientists explaining about the overall topic of MSC's for MS. . . .

I'm glad to see the MSC clinical trial work continuing since there is no firm evidence yet that this will result in clinical efficacy, although I hope it will. Here is the early published clinical data to date, which is not overwhelmingly convincing that the patients are benefitting in a substantial way. But because this was performed mainly on progressive patients, perhaps MSC therapy will show superior benefit for relapsing patients:

It is very clear that if there is any hope that MSC's will provide clinical benefit for MS patients then the isolated MSC population will HAVE to undergo colony expansion. Places that just extract MSC's from the body and then simply reinject the unmanipulated cells back into the body (such as Panama) is a complete scam. Celltex appears to be boosting the MSC population to fantastically good population levels which personally I am really happy to see them doing so. This lends a lot of legitimacy and technical credibility to their operation. The original studies identified a minimum required population in the neighborhood of 1-2M reinfused cells per kg of body weight. Celltex appears to be exceeding this minimum level quite nicely. Here is a paper by the great Prof. Slavin on the subject of phase I data of MSC's-for-MS:

Last note I thought I'd interject. . . . . MSC's for clinical use can be extracted from the body from either adipose fat tissue or the bone marrow compartment. Either way, the collected populations are quite small; usually on the order of only tens-of-thousands of cells, hence the requirement for ex-vivo colony expansion. The question is . . . . what is the difference between the clinical effect of MSC's from these two disparate sources (adipose vs. marrow)? The data is currently very sparse and inconclusive. Although both sets of cells differentiate to the same (connective tissue) function, these two cell origins are not exactly the same. Morphologically they appear slightly different to each other under microscopic examination. What does this mean?. . . no one knows. Or has yet to explain it in a conclusive manner. The adipose MSC's do appear to multiply more efficiently and more quickly, resulting in greater expanded population levels in a shorter period of culturing time. On the other hand marrow-derived MSC's appear to survive through more generations of multiplication cycles. So which source is better?. . . . still not established. The only thing that is known for certain is that they MUST be expanded to have any hope of being beneficially effective in a clinical settiing beyond a placebo effect. So please beware before spending your money to go to Panama to receive useless non-expanded MSC therapy.

Bottom line. . . although MSC therapy can be had in Israel with Prof Slavin (marrow cell source, $32K). I'm glad this is being made available locally (for me in the USA) at Celltex (adipose cell source). Cuts down on the inconvenience of overseas travel. And once I see even a modicum of positive clinical data, for myself I'm going to seriously consider doing it.

georgegoss wrote:I don't mean to butt in here and interrupt the good flow of dialogue. Just wanted to add a couple of additional comments.

Hi George,

thank you for your comment, it is always very welcome as I think you have the best knowledge on the topic here in the forum. Personally, I would be happy if I could read more from you time to time.

I just came from my new neurologist and we talked about stem cells as well. He also thought that theoritically the best solution is HSCT, as this is the only method that tries to erase the root of the disease. Unfortunately, in many countries they can not show as good results as in Heildelberg and many neurologists can not understand what it means to live with ms, so they consider risk differently as we do. Personally, I would go through HSCT if it had a better price tag or there would be a hospital which would do such treatment in my country in a reliable way. It is always better to get a treatment in a place where you can use your own language. Unfortunately, mine is not English.

As for colony expanded MSC infusion, is there more data on safty? As far as I know in certain fields they are using it more commonly. Is that true? The reason why I am thinking about this treatment is to gain some time until HSCT bocomes more of a mainstream and I might be able to get it financed by my state insurance or get it cheaper somewhere in East Europe. So, I would be happy if MSC would do some immunmodulation and support some regeneration for a few years. As far as I know it is cheaper than HSCT. I think this could be an approach for those who are interested in stem cells and who do not have the financial resources for HSCT today, but who are interested in getting it later when it is more available. So, I would be really happy, if I could read more on the topic.

I also read somewhere that MSC treatment comes down to probability, how the stem cells will move to the goal. Eg. when we drop a ball down from a hill top, it is unpredictable which way it gets down the hill. All we know it will get down. Even a small stone can deter tha ball in many ways and the road down the hill is full of stones. All of these things are unpredictable at the start. I think the situation with MSC is a little bit similar today.

First off. . . . your English is so damn good I actually could think you are an english teacher!

And the great point you have made about probability. . . . . just like everything in nature (and medicine), there are no certainties. Just probabilities. So you're right about the fact that it is impossible to predict outcomes with complete precision. It's really all about playing the odds.

HSCT definitely stops the underlying MS disease activity and progression in an enduring way. But also it is completely understandable that paying for such a very expensive procedure is the #1 difficulty for most people.

Regarding MSC therapy. . . . This definitely has real medical science behind it. There are currently two large scale phase I clinical trials being conducted to test for safety and tolerability of the treatment at the Cleveland Clinic and at Royal College of London Hospital. This is on top of the work already completed in Israel at Hadassah Hebrew Medical Center. Although the clinical trials have not yet directly measured the efficacy for a targetted patient population, there has been a substantial amount of safety profiling done for the treatment already. And MSC therapy itself so far appears to be rather safe. There is a "theoretical" possibility of MSC's lodging in pulmonary tissue that may cause benign fibroblastic growths of the lung tissue that could impair breathing function. Such a condition would require surgery to correct. However, so far this has not been shown to be a problem. So worst case probably MSC therapy is just not very effective, but also not very dangerous. But the upside possibility could be quite good in restoring lost nerve function. Seems to me MSC therapy (with colony expansion) has a favorable risk vs reward ratio and for myself I would feel comfortable doing it (at a safe treatment center where they use good health practices).

My own theory is that perhaps a two step treatment to attack MS might be quite good. . . First HSCT to stop the underlying MS disease and then secondly MSC's to repair damage to improve/restore lost function. But if I couldn't or didn't want to get HSCT, then for me my next choice would be colony-expanded MSC therapy alone. Especially since MSC's appear (for some people at least) to also (at least temporarily) control the body's overactive immune system that causes MS.

A video of an isolated patient case that appears to have benefitted well from MSC therapy (but this is not a scientifically controlled treatment case and does not necessarily translate to anyone else). But at least it shows what's "possible". . . .

Mainly you bring up an excellent point regarding the legality of what Celltex is doing in the United States. The US Federal Government has reserved to sole right to regulate drugs and things put into the human body that are manufactured or "manipulated" (which colony expanded MSC's are most certainly "manipulated"). So at the federal level clearly Celltex is breaking the law. It is the State Government of Texas that passed their own law autorizing Celltex's license to operate. So clearly there is an understood conflict here between the US federal Government and the state Government of Texas. I see this situation very much similar to the State of California legalizing medical marajuana in which it is not legal under federal law. For the time being, the US federal Government has decided to leave California (mostly) alone and let them continue even in violation of Federal law. Probably it has a lot to do with resouces since the Federal Government does not have enough enforcement staff to go in and shut down all the Marijuana operations in California.

The situation with Celltex is similar, except that it would be easy for the Federal Government to go in and shut down Celltex since it is just a single operation. The state of Texas wouldn't be able to do anything about it. So it will be interesting to see how this plays out. Celltex could easily move off shore (across the border in Mexico?) and avoid this federal regulatory control, if they wished. But definitely they are playing with fire since the officers of the company could also be charged with federal crimes if the US Government decided to go after them.

Also from the articles, it seems quite disturbing that they found some highly suspicious procedural violations. Including the one where a bottle was labled in English as a "reagent," but the label under it written in Korean indicated it to be a cleaning or sanitizing agent. Whoops! Scary.

Beyond the legal and protocol issues (of course both important, especially making sure they are running an operation with sound and safe protocols), if just looking at the fundamental science I still am glad to see such work continue. If Celltex can ensure that all their employees are following safe procedures and are delivering the stated claims (correct population of correct and sterile colony expanded MSC's), then this MSC therapy has the possibility to be quite efficacious for the treatment of MS. Even though not quite (proven clinically in-vivo) there yet, hopefully the evidence will emerge clearly indicating positive benefit.

For now, Celltex clearly needs to get much of their act cleaned up. Hopefully the next FDA audit results will be better. I prefer to see Celltex remain in the United States because we, as consumers and patients are better off if Celltex continues to operate under the close watchful eyes of the FDA.

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